Model Number 2420-0500 |
Device Problems
Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
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Patient Problem
No Code Available (3191)
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Event Date 10/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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The customer reported that an occlusion alarm occurred on a pump and could not be cleared.The user observed that the set had collapsed inside of the pumping module.A blood pressure medication was being administered at the time of the event, and some small blood pressure variability was noted during troubleshooting.The user massaged the tubing and continued the infusion.No other effect to the patient was reported.Biomed conducted an investigation on the set and found that the set was visibly deformed and fused.
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Event Description
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The customer reported that an occlusion alarm occurred on a pump and could not be cleared.The user observed that the set had collapsed inside of the pumping module.A blood pressure medication was being administered at the time of the event, and some small blood pressure variability was noted during troubleshooting.The user massaged the tubing and continued the infusion.No other effect to the patient was reported.Biomed conducted an investigation on the set and found that the set was visibly deformed and fused.
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Manufacturer Narrative
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The customer¿s report of an occlusion alarm and collapsed tubing was not confirmed.Visual inspection showed no anomalies.There was no evidence of the pump chamber being collapsed.Functional testing found no anomalies.The root cause of the customer¿s report could not be identified.
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Search Alerts/Recalls
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